Latest Pharma and Biotech News
Biotechnology
13 July 2026 Elevar Therapeutics, a majority-owned subsidiary of South Korea's HLB , has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application seeking approval of rivoceranib in combination with AiRuiKa (camrelizumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.
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Biosimilars
The advent of biologics has opened doors for the treatment of several acute and chronic medical conditions.1 Unlike conventional medicines, biologics are derived from living organisms using complex biomedical processes. As a result, development of biologics is more complicated as compared to conventional drugs.2 14 February 2023
Biosimilars
Icelandic firm Alvotech and marketing partner German drugmaker STADA Arzneimittel today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab). 9 February 2023
Biosimilars
Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq, offers his vision for affordable global healthcare in an Expert View piece. 7 February 2023
Biosimilars
The American business of South Korea's Celltrion Healthcare has appointed Thomas Nusbickel as chief commercial officer. 7 February 2023
Biosimilars
Privately-held Advanz Pharma has announced that it has entered into an exclusive agreement with Alvotech, an Icelandic biosimilars company, for the exclusive license and supply rights for a proposed copy of Xolair (omalizumab). 6 February 2023
Biosimilars
Sandoz, the generics and biosimilars business unit of Swiss pharma giant Novartis that is soon to be spun out, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. 6 February 2023
Biosimilars
Two decades and more than $200 billion later, AbbVie has finally lost its exclusive hold on the US market for biologics based on Humira (adalimumab). 31 January 2023
Biosimilars
Biologic products have revolutionized the treatment options for many diseases and typically carry favorable benefit–risk profiles compared with small molecule drugs. 31 January 2023
Biosimilars
The US Food and Drug Administration (FDA) has released the BsUFA III Regulatory Science Pilot Program: Research Roadmap. 26 January 2023
Biosimilars
Indian drugmaker Dr Reddy’s Laboratories has completed the trial program for its proposed rituximab biosimilar candidate, and will move ahead with global regulatory interactions. 23 January 2023
Biosimilars
Adding to European Commission clearance in November last year, German drugmaker STADA Arzneimittel and Sweden’s Xbrane Biopharma announced that their Ximluci (ranibizumab), a biosimilar referencing Lucentis, has been granted marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 17 January 2023
Biosimilars
Shares of India’s largest biotech firm Biocon slumped 2.4% to record a new 52-week low, after its subsidiary Biocon Biologics informed that the US Food and Drugs Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for its Insulin-R product. 13 January 2023
Biosimilars
California, USA-based Coherus BioSciences’ shares closed up almost 10% at $9.85 yesterday, when it announced the execution of a binding term sheet with Germany’s Klinge Biopharma for the exclusive US commercialization rights to FYB203, a biosimilar candidate to Eylea (aflibercept). 11 January 2023
Biosimilars
Icelandic firm Alvotech and the US subsidiary of Israel’s Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Johnson & Johnson’s Stelara (ustekinumab). 6 January 2023
Biosimilars
South Korea’s Samsung Bioepis says that Health Canada has approved its Hadlima (also known as SB5) - a citrate-free, high concentration (40mg/0.4 ML) formulation of biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 3 January 2023
Biosimilars
South Korea’s Celltrion Healthcare has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA). 28 December 2022
Biosimilars
The European Commission has published a study examining the public procurement practices and their impact on medicines supply and availability. The study confirms that awarding multiple winners and using additional criteria other than price (most economically advantageous tender – MEAT criteria) would be more sustainable procurement. 22 December 2022
Biosimilars
Canada’s largest public drug plan has announced a transition to cost-saving biosimilar medicines. 21 December 2022
Biosimilars
Biosimilar medicines deliver access for patients suffering from serious and debilitating conditions such as cancer, auto immune diseases, and diabetes. 13 December 2022
Biosimilars
The US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) submitted by biotech major Biogen for BIIB800, a biosimilar candidate referencing Roche’s Actemra, an anti-interleukin-6 receptor monoclonal antibody. 12 December 2022
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Biosimilars
Israel based Teva Pharmaceutical Industries and South Korea’s Samsung Bioepis have entered into a license and commercialization agreement for Opuviz (aflibercept), a biosimilar referencing Eylea (aflibercept), in Canada. 10 July 2026
Biosimilars
Israeli drugmaker Teva Pharmaceutical Industries has expanded its biosimilars pipeline through a global licensing agreement with Polpharma Biologics for a proposed copy of Roche’s multiple sclerosis drug Ocrevus (ocrelizumab). 9 July 2026
Biosimilars
South Korean biosimilar specialist Samsung Bioepis today announced that it has entered into a license agreement with Proteina Co to collaborate on a government-supported national R&D initiative aimed at developing AI-based antibody therapeutics. 9 July 2026
Biosimilars
Sandoz has launched a direct-to-consumer platform in the USA, taking an unusual step for a global generics and biosimilars manufacturer by allowing self-pay patients to purchase medicines directly rather than through the traditional pharmacy distribution system. The new service, called Sandoz Direct, debuts with Omnitrope (somatropin), the company's biosimilar growth hormone therapy. 6 July 2026
Biosimilars
South Korea’s Samsung Bioepis today announced that the Phase I and Phase III studies on SB27, a proposed biosimilar to Keytruda (pembrolizumab), have met their primary endpoints. 29 June 2026
Biosimilars
Icelandic biosimilars company Alvotech announced the successful closing of its public offering. The firm’s shares were barely changed at $3.90 on the announcement today. 18 June 2026
Biosimilars
South Korean biosimilar specialist Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to Pyzchiva, Samsung Bioepis’ biosimilar referencing Johnson & Johnson’s (NYSE: JNJ) Stelara (ustekinumab). 18 June 2026
Biosimilars
Alongside its Biosimilars Council, the Association for Accessible Medicines (AAM) applauds the positive momentum for America’s patients, as the Biosimilar Red Tape Elimination Act and the Medication Affordability and Patent Integrity Act both pass out of the Senate HELP Committee. 18 June 2026
Biosimilars
Switzerland-based Sandoz, a leader in affordable medicines, today inaugurated a new biosimilar development center in Ljubljana, Slovenia, to strengthen and expand its in house biosimilar capabilities. 17 June 2026
Biosimilars
Israel-headquartered Teva Pharmaceutical Industries has announced the launch of Ahzantive (aflibercept), a biosimilar to Eylea, in Europe further strengthening the company’s growing biosimilars portfolio and expanding its presence in ophthalmology. 4 June 2026
Biosimilars
South Korean biosimilar specialist Samsung Bioepis announced the launch of Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing eye diseases drug Eylea (aflibercept), across Europe, starting today. 29 May 2026
Biosimilars
In recent years, some stakeholders have held the view that Belgium is a difficult or even unattractive country for biosimilars, according to a website posting by trade group pharma.be. 26 May 2026
Biosimilars
Olayan Financing Company (OFC) has made a minority equity investment in Jordan-headquartered MS Pharma, a leading pharma player in the Middle East North Africa (MENA) region that specializes in the development, production and distribution of a broad portfolio of generic and biologic therapies. 20 May 2026
Biosimilars
The US Food and Drug Administration (FDA) on Friday approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis-ntri golimumab-sldi) to treat rheumatoid arthritis and ulcerative colitis. 16 May 2026
Biosimilars
Swiss drugmaker Sandoz today confirmed that the European Commission has granted marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals. 15 May 2026
Biosimilars
Industry group Medicines for Europe has urged policymakers to strengthen support for biosimilar medicines, arguing that wider uptake could improve patient access to biologic therapies while reinforcing Europe’s pharmaceutical resilience. 7 May 2026
Biosimilars
US generic drugmaker Lannett said the US regulator has approved Langlara (insulin glargine-aldy), an interchangeable biosimilar to Sanofi’s long-established diabetes treatment Lantus (insulin glargine). 6 May 2026
Biosimilars
Swiss generics and biosimilars firm Sandoz is entering what it calls a “golden decade” for biosimilars from a position of financial strength and renewed independence, according to Rebecca Guntern, chief commercial officer. 24 April 2026
Biosimilars
US drugmaker Amneal Pharmaceuticals, a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines, has entered into a definitive agreement to acquire 100% of Kashiv BioSciences. 23 April 2026
Biosimilars
Israeli drugmaker Teva has regained the upper hand in its long-running migraine patent dispute with US pharma major Eli Lilly, after a federal appeals court reinstated a $176.5 million jury award tied to rival drugs Ajovy (fremanezumab) and Emgality (galcanezumab). 20 April 2026
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